Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 8:15 PM
Study NCT ID:
NCT00001750
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Treatments for Multiple Myeloma
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Randomized Trial of Autologous Transplantation With Filgrastim Versus Stem Cell Factor/Filgrastim-Primed CD34-Enriched Peripheral Blood Cells for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2002-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some drugs have the ability to push stem cells (the cells responsible for producing new cell types) out of the bone marrow and into the blood stream. The steps involved in this process are still poorly understood. However, a better understanding of this process could lead to improved results in transplantation, cancer treatment, and contribute to the development of new genetic therapies for a wide variety of disorders.
In this study researchers plan to compare two different treatments, both that mobilize (push) stem cells out of the bone marrow into the blood stream. In addition, researchers will attempt to determine which is the most efficient at mobilizing blood cells of patients with multiple myeloma.
Information and knowledge gained from this study will help to design future transplantation and genetic therapy research studies.
In this study researchers plan to compare two different treatments, both that mobilize (push) stem cells out of the bone marrow into the blood stream. In addition, researchers will attempt to determine which is the most efficient at mobilizing blood cells of patients with multiple myeloma.
Information and knowledge gained from this study will help to design future transplantation and genetic therapy research studies.
Detailed Description:
Some drugs, such as hematopoietic cytokines, result in mobilization of primitive stem cells out of the bone marrow space and into the blood, but the mechanisms of this process are still poorly understood. A better understanding of this process could greatly improve clinical results in transplantation, cancer treatment, and potentially genetic therapy of a wide variety of disorders. In this protocol, we will study two different mobilization treatments and compare how efficient they are at increasing the number of primitive cells in the blood in patients with multiple myeloma. These cells will be collected by apheresis, and used for autologous transplantation following high dose chemotherapy. This aggressive approach to treatment in multiple myeloma has been shown to improve remission rates and survival without active disease. The use of a larger number of blood stem cells may decrease the toxicity associated with the procedure. In the research laboratory, we will study a number of characteristics of the primitive cells in the blood and the bone marrow after treatment with the mobilizing drugs. These studies will help us to design future transplantation and genetic therapy protocols.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 98-H-0154 | None | None | View |